This position is responsible for coordinating and participating in clinical research studies conducted by AHH investigators. The Clinical Research Nurse is required to make decisive decisions with rapid response to urgent situations. Must multi-task while conducting daily activities such as physical exams, placing IV’s, administering investigational drug, and vital signs. Performs a variety of patient/subject-related administrative duties to support activities that meet objectives of assigned research protocol(s).
- Provides subject screening, care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals.
- Confers with subject and physician to explain purpose of study.
- Explains diagnostic procedures and method of treatment to answer subject and family concerns.
- Obtains written consent for subject to participate in a study prior to initiation of any protocol procedures.
- Performs procedure and/or administer Investigational Drugs in strict compliance to the study protocol.
- Oversees and monitors the well-being and safety of study participants.
- Coordinates research activities, including screening, consenting and scheduling tests or exams for study subjects.
- Collects pertinent information and data from subject charts and records, subject interviews and other sources.
- Completes case report forms (CRFs) in accordance with research protocol guidelines.
- Maintains accurate records of the receipt, inventory and dispensation of study drugs and/or devices and materials.
- Reviews CRFs, source documentation and study files with representative(s) from sponsor or from the Food and Drug Administration (FDA). Makes necessary corrections to CRFs and submits requested documentation in a timely manner.
- Collects and processes adverse events.
- Complies with standard operating procedures of AHH, sponsor and institutional review board (IRB).
- Compiles and submits reports, documents and correspondence as necessary to the IRB or sponsor.
- Assists with study initiation visits and monitoring visits by research sponsors.
- Provides training and direction to new personnel on protocol procedures.
- Maintains current knowledge of regulations governing clinical research.
- Initiates and participates in problem-solving discussions within a functional teamwork concept.
- Maintains all research patient records with strictest confidentiality.
- Attends research meetings and conferences as required.
- Performs special projects as requested.
- Education: Graduate of an accredited program of nursing.
- Licensure/Certification: Current state licensure or licensure from a state within the Nursing Compact. Current BLS certification required within 30 days of placement in position. Certification is to be renewed by recommended renewal date on certification card. CCRC and/or CCRP preferred.
- Experience: Minimum of at least two (2) years experience in clinical research setting or related field required. Experience in specialty area (i.e. Cardiology/cardiovascular wound care, peripheral vascular disease) preferred.